ALADDIN User Manual Rev 13 Feb 2013

User Manual

98 Pages

File Type: PDF

File Size: 4.04 MB

File Name: aladdin_user_manual_rev_13_feb_2013.pdf

Preview

Page 1

ALADDIN

- User manual

Rev. 13 of 20/02/2013

ALADDIN User manual 0476

Rev. 13 - 2013

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Thank you for choosing this product. Please read the information in this manual carefully. You must be familiar with its contents in order to work with the device.

Manufacturer

Distributor

VISIA imaging S.r.l. Via C. E. Gadda, 15 52027 San Giovanni Valdarno (AR) Italy

Topcon Europe Medical B.V. Essebaan 11 2908 LJ Capelle a/d IJssel The Netherlands www.topcon.eu [email protected]

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Contents 1

Intended Use.................................................................................................................................. 7 1.1

Description of functionalities .................................................................................................... 7

1.2

Users....................................................................................................................................... 8

1.3

Interaction with the patient...................................................................................................... 8

1.4

Places of use............................................................................................................................ 8

Accessibility and scope of the manual .............................................................................................. 9

Introduction................................................................................................................................. 10 3.1

Main characteristics ............................................................................................................... 10

Precautions .................................................................................................................................. 11 4.1

EMC table.............................................................................................................................. 11

Symbols ....................................................................................................................................... 14 5.1

Labelling on the device........................................................................................................... 15

Safety instructions ........................................................................................................................ 16 6.1

General ................................................................................................................................. 16

6.2

Electrical safety...................................................................................................................... 16

6.3

LED emission safety................................................................................................................ 16

6.4

Installation with external devices ............................................................................................ 17

6.5

Transport and packaging ........................................................................................................ 17

6.6

Cleaning ................................................................................................................................ 17

6.7

Package contents ................................................................................................................... 17

6.8

Checking the measurements................................................................................................... 18

Product warranty and reliability .................................................................................................... 18

Legal provisions ............................................................................................................................ 19

Components................................................................................................................................. 20 9.1

Main Body............................................................................................................................. 20

9.2

Other components ................................................................................................................. 21

Installation /uninstallation of the system ....................................................................................... 22

10.1

Installing the system .............................................................................................................. 23

10.2

Uninstalling the system .......................................................................................................... 26

ALADDIN accessories and equipment............................................................................................. 29

11.1 12

Setting up the instrument ............................................................................................................. 30

12.1 13

Standard equipment .............................................................................................................. 29

Connection modes ................................................................................................................. 30

OPERATING INSTRUCTIONS ........................................................................................................... 31 3

ALADDIN 13.1

- User manual

Rev. 13 of 20/02/2013

General description of functionalities...................................................................................... 31

13.1.1

General instructions........................................................................................................ 31

13.2

Checking the calibration......................................................................................................... 32

13.3

Patient entry/selection........................................................................................................... 34

13.3.1

Creating a new patient.................................................................................................... 34

13.3.1.1

13.3.2

Entering s pecial characters: ..........................................................................................34

Selecting or modifying a patient ...................................................................................... 36

13.3.2.1

Open an examination or acquire data for the se lected patie nt ............................................36

13.3.2.2

Delete or edit the selected pa tient .................................................................................36

13.3.2.3

Insert the Post-Op (after s urgery) refraction data .............................................................37

13.4

Acquisition environment: general instructions ......................................................................... 38

13.4.1

Description of the Acquisition screen............................................................................... 40

13.4.1.1

Errors in Measurements ...............................................................................................41

13.4.1.2

Biometry ...................................................................................................................42

13.4.1.3

Pupillometry ..............................................................................................................42

13.5

Full biometry acquisition (AL-ACD-K) ....................................................................................... 43

13.5.1

Acquisition procedure..................................................................................................... 43

13.5.2

Manual acquisition of the anterior chamber..................................................................... 44

13.6

Acquisition of axial length measurements (AL)......................................................................... 45

13.7

Acquisition of the anterior chamber measurement (ACD)......................................................... 46

13.8

Keratometry acquisition (KER) ................................................................................................ 48

13.9

Acquisition of the dynamic, photopic, mesopic pupillometry ................................................... 49

13.10

Report printing................................................................................................................... 51

13.11

IOL CALCULATION............................................................................................................... 52

13.11.1

Data ........................................................................................................................... 52

13.11.2

IOL CALCULATION ....................................................................................................... 54

13.11.3

Toric IOL calculation.................................................................................................... 56

13.11.4

Post Refractive IOL calculation..................................................................................... 58

13.12

MEASUREMENTS................................................................................................................ 61

13.12.1

TOPOGRAPHIC MAP (KER) ........................................................................................... 61

13.12.1.1

Topographic map indices..............................................................................................62

13.12.1.2

Keratometry ..............................................................................................................62

13.12.1.3

Keratorefractive indices ...............................................................................................62

13.12.1.4

Keratoconus ..............................................................................................................63

13.12.1.5

Pupil.........................................................................................................................64

13.12.1.6

Profile ......................................................................................................................64

13.12.2

Zernike ....................................................................................................................... 66 4

ALADDIN

AXIAL LENGTH (AL)...................................................................................................... 68

13.12.4

ANTERIOR CHAMBER DEPTH (ACD) .............................................................................. 69

13.12.5

PUPILLOMETRY (PUP).................................................................................................. 70

13.12.5.1

Display......................................................................................................................70

13.12.5.2

Sequences .................................................................................................................70

13.12.5.3

Dynamic....................................................................................................................71

13.12.5.4

Photopic, Mesopic ......................................................................................................71

13.12.5.5

Functions ..................................................................................................................71

13.12.5.6

Graphs ......................................................................................................................71

SETTINGS ........................................................................................................................... 75

13.13.1

General ...................................................................................................................... 75

13.13.2

Measurements ........................................................................................................... 76

13.13.2.1

Scales .......................................................................................................................76

13.13.2.2

Printer ......................................................................................................................77

13.13.2.3

Pupillometry ..............................................................................................................77

13.13.3

Surgeons .................................................................................................................... 78

13.13.4

IOL ............................................................................................................................. 79

13.13.4.1

Disclaimer .................................................................................................................79

13.13.4.2

Preset.......................................................................................................................79

13.13.4.3

IOL list ......................................................................................................................80

13.13.5

Report........................................................................................................................ 82

13.13.6

Admin ........................................................................................................................ 83

13.13.6.1

Updating the integra ted software ..................................................................................84

13.13.6.2

Backup .....................................................................................................................84

13.13.6.3

Restore .....................................................................................................................84

13.13.6.4

Closing the software ....................................................................................................84

Operating voltage and fuse change................................................................................................ 85

14.1

14.2 15

Rev. 13 of 20/02/2013

13.12.3

13.13

- User manual

Changing the operating voltage .............................................................................................. 85 14.1.1.1

Step 1.......................................................................................................................85

14.1.1.2

Step 2.......................................................................................................................85

14.1.1.3

Step 3.......................................................................................................................85

14.1.1.4

Step 4.......................................................................................................................86

14.1.1.5

Step 5.......................................................................................................................86

14.1.1.6

Step 6.......................................................................................................................86

Changing the fuse .................................................................................................................. 87

Technical specifications................................................................................................................. 88

15.1

General ................................................................................................................................. 88

15.2

Electrical data ........................................................................................................................ 88

15.3

Optical radiation.................................................................................................................... 89 5

ALADDIN

- User manual

Rev. 13 of 20/02/2013

15.4

Information on measurements ............................................................................................... 90

15.5

Environmental conditions....................................................................................................... 91

15.6

Mechanical Specifications....................................................................................................... 91

15.7

Other Specifications:.............................................................................................................. 91

Declaration of conformity ............................................................................................................. 92

Appendix: Installing an external printer......................................................................................... 93

17.1

Getting drivers and transferring them to ALADDIN................................................................... 93

17.2

Disable the Write Filter........................................................................................................... 93

17.3

Installing a local printer (USB) ................................................................................................. 94

17.4

Installing a network printer (LAN) ........................................................................................... 97

ALADDIN

- User manual

Rev. 13 of 20/02/2013

1 Intended Use “ALADDIN is intended for the biometric determination of ocular measurements for axial length (AL), corneal topography and keratometry (corneal radius and keratometric indices), corneal diameter (white-towhite), pupillometry (pupil size and deviation from the centre) and anterior chamber depth (ACD). For patients requiring an intraocular lens (IOL) implant, the device also supports physicians in the performance of calculations to determine the appropriate IOL power and type of implant. ALADDIN is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician. Use for any purposes other than those intended is the user's responsibility.

1.1 Description of functionalities Aladdin is a combined device for the measurement of various parameters used in the application of intraocular lenses. The instrument can work in two different modes: 1. Consecutive acquisition of all the measurements available on the eye 2. Individual acquisitions for each type of measurement Aladdin includes five types of measurement in a single instrument. • Axial length • Corneal topography and keratometry • Corneal diameter (white-to-white) • Pupillometry • Anterior chamber depth Axial length is the distance between the corneal apex and the fovea. It is measured with a low-coherence interferometry system with a super luminescent diode. The measuring range is from 15 mm up to over 38 mm. Keratometry is used to measure the corneal curvature. It is based on the reflection of the Placido disk on the eye at a controlled working distance for high measuring precision. Aladdin allows the user to acquire the corneal topography of the eye. The “Corneal Map” is obtained from the reflection of 24 rings of the Placido disk at a distance of around 80 millimetres from the patient's eye. With the acquisition of the corneal topography it is possible to determine the Corneal Diameter, also called "white- to- white" distance. The pupillometry is performed with LEDs of different wavelengths. In particular, the instrument uses infrared LEDs to dilate the pupil and white LEDs to reproduce photopic light conditions and to contract the pupil (dynamic pupillometry). ACD (anterior chamber depth) is the distance between the anterior surface of the crystalline (anterior capsule) and the outermost stratum of the cornea (epithelium), measured along the optical axis where the 7

ALADDIN

- User manual

Rev. 13 of 20/02/2013

latter is biggest. This measurement is performed using the reflection principle of a slit light projected onto the anterior surfaces of the eye. Aladdin has an onboard PC with the dedicated software that provides all the functionalities described. The information obtained from the measurements can be used for various applications, for example: Cataract operations, IOL calculation, IOL toric calculation and post lasik calculation. The intraocular lens power suggestion is made using scientifically recognised formulae: Holladay 1, Haigis, Hoffer Q, SRK / T, SRK II, Camellin-Calossi ....

1.2 Users Users: medical staff, opticians, ophthalmologists. For surgery and intraocular lens implantation, the device can only be used under medical supervision. For the other applications, the device must be used by qualified personnel.

1.3 Interaction with the patient The patient does not actuate the controls, is positioned with his/her chin on the chin rest and forehead on the forehead rest and is asked to keep still and to look with one eye at the fixation point. The patient may be elderly, disabled or a child, but the device is to be controlled by the aforementioned specialised personnel.

1.4 Places of use The intended places of use are: health care centres, doctors' surgeries, operating theatres.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

2 Accessibility and scope of the manual Keep these instructions in a safe place close to the device. The manual must be at hand at all times. For best use of the instrument, read the instructions carefully. The purpose of this manual is to inform the user as to all the device's functions, settings, safety, installation, maintenance, cleaning and storage instructions.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

3 Introduction 3.1 Main characteristics ALADDIN is a multifunction medical device used for the detection of various biometric parameters, particularly useful for the calculation of spherical, toric or personalised intraocular lenses. It records a range of parameters acquired using different techniques. Optical Biometry: by means of the low-coherence optical interferometry method, ALADDIN executes highly accurate axial length measurements (between 1 and 38mm). Anterior chamber depth: slit light projection: by projecting a slit of certain characteristics onto the eye, you can determine the length of the optical axis of the anterior chamber, a very important measurement for the calculation of IOL using the latest methods. Topography: it is the only instrument (of all optical interferometric biometers) that allows the user to acquire a topographic map of the patient of approximately 6,200 points using a 24-ring Placido disk. This provides high accuracy and detail in the description of the corneal surface. This measurement also provides a kerometry at 3mm, 5mm and 7mm (with the respective corneal astigmatism). Pupillometry: to guarantee a further accuracy factor in the calculation of intraocular lenses, the instrument has a set of LEDs onboard that allows you to measure the Photopic, Mesopic and Dynamic pupillometry. White-to-White: as a result of the corneal topography, you can then, by means of an internal software algorithm, obtain a precise white-to-white value, i.e. the corneal diameter recorded at the limbus. On the basis of the measurements made, the instrument can propose a choice of intraocular lens power. This is based on internationally recognised formulae: Holladay 1, Haigis, Hoffer Q, SRK / T, SRK II, CamellinCalossi Similarly, a database of intraocular lenses is also implemented. Before the calculation is made, the data for the desired lens must be entered. ALADDIN also covers all the basic functions of corneal topographies for recording the most important keratorefractive parameters.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

4 Precautions This electronic instrument is a precision tool. Make sure you use it and keep it in a suitable place, at a normal temperature, humidity and atmospheric pressure out of direct sunlight. • • • • •

To ensure that it works properly, install the instrument in a vibration-free location. Correctly connect all cables before use. Use the recommended network voltage. When the instrument is not in use, turn off the power supply and protect it from the sun and from dust. To obtain accurate and reliable measurements, keep the measuring cone clean and free of dust.

This product conforms to the EMC standard (IEC 60601-1-2 3rd Edition). -

ELECTRICAL MEDICAL DEVICES require special EMC precautions and must be installed and activated in accordance with the EMC instructions provided in the accompanying documentation. Portable RF communication instruments may interfere with medical devices. Use of accessories and cables other than those supplied with the instrument, except cables sold by the equipment manufacturer as spare parts, may lead to an increase in emissions and reduce the device's or system's immunity. The device must not be used in contact with other devices. If use of the device in contact with other instruments is unavoidable, check that the device works properly in the required configuration.

4.1 EMC table Emission issues ALADDIN is intended for use in the electromagnetic environment specified below. The customer or user must ensure that it is used only in such an environment Emission test

Compliance

Electromagnetic environment - guide

RF emissions CISPR 11

Group 1

ALADDIN uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in neighbouring electronic devices.

RF emissions CISPR 11

Class B

ALADDIN is suitable for use in all residential buildings and those directly linked to a low-voltage supply network that supplies residential buildings.

Harmonic Emissions IEC 61000-3-2

Class A Compliant

Emissions of voltage fluctuations/flicker IEC 61000-3-3

Compliant

The device can be used in all buildings, including residential buildings and those connected to the low-voltage mains network that supplies residential buildings.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Immunity issues ALADDIN is intended for use in the electromagnetic environment specified below. The customer or user must ensure that it is used only in such an environment Immunity issues

Test level EN 60601-1-2

Compliance level

Electromagnetic environment - guide

Electrostatic discharge (ESD) EN 61000-4-2

± 6kV on contact ± 8kV in air

Floors must be in wood, concrete or ceramic. If floors are covered with synthetic material, the relative humidity must be at least 30%

±2kV power supply

±2kV power

lines

supply lines

Transients/fast electric trains EN 61000-4-4

±1kV differential Surge EN 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11

mode ±2kV common mode

±1kV differential mode ±2kV common mode

< 5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

< 5% UT (>95% dip in UT) for 5 seconds

Power frequency magnetic fieldEN 61000-4- 3 A/m 8

Mains power quality must be that of a typical commercial or hospital environment.

Mains power quality must be that of a typical commercial or hospital environment. If the user requires the device to work continually even during a power cut, we recommend powering the device with an uninterruptable power supply (UPS) or a battery.

Power frequency magnetic fields must have levels characteristic of a typical commercial or hospital environment.

3 A/m

ALADDIN

- User manual

Rev. 13 of 20/02/2013

RF immunity issues ALADDIN is intended for use in the electromagnetic environment specified below. The customer or user must ensure that it is used only in such an environment Immunity test

Test level EN 60601-1-2

Compliance level

Electromagnetic environment - guide

Conducted RF EN 61000-4-6

3 Veff 150kHz to 80MHz

Portable and mobile RF communication devices must be used no closer to any part of the ALADDIN device, including the cables, than the recommended separation distance, calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Radiated RF EN 61000-4-3

3 Veff 80MHz to 2.5GHz

d = 1.2 ⋅√P from 150kHz to 80MHz d = 1.2 ⋅√P from 80 MHz to 800 MHz d = 2.3 ⋅√P from 800 MHz to 2.5 GHz where P is the nominal maximum output power of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined in an electromagnetic survey of the site, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended separation distance between portable and mobile radio communication devices and the ALADDIN device ALADDIN is intended for use in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices (transmitters) and the ALADDIN device as recommended below, according to the maximum output power of the radio communication devices.

Maximum nominal output power of the transmitter (W)

Separation distance according to the frequency of the transmitter (m) 150kHz to 80MHz

80MHz to 800MHz

800MHz to 2GHz

d = 1.2 ⋅√P

d = 2.3 ⋅√P

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters with maximum output powers not listed above, the recommended separation distance d in metres (m) can be calculated using the equation applicable to the frequency of the transmitter, where P is the nominal maximum output power of the transmitter in Watts (W) according to the transmitter manufacturer. Note: (1) At 80 MHz and 800 MHz the separation distance of the higher frequency range applies (2) These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

5 Symbols Symbols

IEC publications

IEC 60417-5840

Description

CLASS II DEVICE ACCORDING TO EN 60601-1 APPLIED PART TYPE B

WARNING: PART CONNECTED TO HIGH VOLTAGE (220-230V / 110-120V)

PRODUCT COMPLIANT WITH DIRECTIVE 93/42/EC

CORNEAL TOPOGRAPHY ACCORDING TO ISO 19980:2005

Type A

IEC 60417-5032

ALTERNATING CURRENT

EN ISO 15223-1

WARNING

EN ISO 15223-1

REFERENCE OR MODEL NUMBER

EN 60601-1

EN ISO 15223-1

SEE USER MANUAL

MANUFACTURER

ALADDIN

- User manual

CLASS 1M LED PRODUCT

EN 60825-1

EXEMPT GROUP EN62471

EN 62471

Rev. 13 of 20/02/2013

CLASS 1M PRODUCT ACCORDING TO EN 60825-1

PRODUCT CLASSIFIABLE AS EXEMPT GROUP IN ACCORDANCE WITH EN 62471

LASER RAY HAZARD SIGNAL

This symbol is applicable to EU member states only. In order to prevent potential negative effects on the environment and on human health, this instrument must be disposed of (i) for EU member states, in accordance with WEEE provisions (Directive on waste materials including electrical and electronic devices), or (ii) for all other countries, in accordance with local recycling provisions and laws.

5.1 Labelling on the device

ALADDIN

- User manual

Rev. 13 of 20/02/2013

6 Safety instructions 6.1 General • • •

ALADDIN should be used only for its intended purposes as detailed in this manual. It must be installed by qualified personnel. The device must be used in the environmental conditions as specified in this document.

•

If the device has just been delivered or has been subjected to thermal shock, wait at least one hour before making measurements on patients. Keep this manual at hand close to the device at all times.

• •

The physician or device user must inform the patient of the pertinent safety instructions and ensure that they are adhered to.

•

Perform all the control functions (detailed in the relative section in this document) before carrying out measurements on patients.

•

Only personnel with the appropriate training and experience may use the device and interpret the results. Turn off the device if it is not going to be used for a long period of time. It is advisable to use the device in an unlit environment, especially when measuring the anterior chamber depth.

• • •

If external forces act on the device (e.g. if it is knocked or dropped), it must be thoroughly checked before proceeding to examine patients. To do this, refer to the relative section in this manual. If necessary, send the device in for repair.

• • •

Use only original ALADDIN accessories and spare parts. Remove all the covering (dust sheet) from the device before turning it on. Do not use the device close to highly inflammable materials or in areas with an explosion risk.

• •

Unauthorised installation of software in the device is not permitted. After the examination the patient may be slightly dazzled. It is recommended to advise the patient to wait a few minutes before driving or doing anything that requires perfect vision.

6.2 Electrical safety • •

ALADDIN has an onboard power supply unit installed. For connection to the mains, use only the manufacturer-approved cables provided with the device. Before performing maintenance on the device, turn it off and disconnect the power cable.

6.3 LED emission safety ALADDIN has a series of LEDs of various types and powers installed. All the characteristics are detailed in the Technical Specifications section in this manual. The device falls within class 1M according to EN 60825-1. All sources are classifiable as EXEMPT GROUP according to EN 62471. 16

ALADDIN

- User manual

Rev. 13 of 20/02/2013

6.4 Installation with external devices ALADDIN complies with the CE marking requirements. •

Before connecting an external device, such as a computer, printer, monitor, keyboard, mouse or other devices, make sure that they comply with the EN 60950-1 standard and have the CE marking.

•

When ALADDIN is installed in rooms for medical use, the PC and the connected printer must be powered by means of an IEC 60601-1 compliant insulating transformer.

•

If ALADDIN is installed in rooms for medical use without a computer, it is not necessary to use an insulating transformer.

•

Do not use mobile phones or other devices not compliant with the requirements of class B EMC close to ALADDIN.

6.5 Transport and packaging • • • •

The device must be transported and stored in its original packaging. For the storage and transport conditions, refer to the relative section in this document. Carefully keep the original packaging in order to use it if you need to transport the device. To move the device for short distances (without packaging) and to insert it in and remove it from the original packaging, grip the device with both hands, one on the front headrest arch and the other in the recess on the rear of the device (where the locking system is).

•

Completely unscrew the two transportation locks and the semi-lock (Figure 5) before use.

•

Lower the instrument to its minimum height using the joystick, then lock ALADDIN using the instrument semi-lock and the two “instrument locking devices” for transportation (Figure 5).

6.6 Cleaning •

Regularly clean dust off the device using a soft cloth. For more persistent superficial dirt, use a soft cloth wetted with water or alcohol at maximum 70%.

•

Be careful not to get the device wet and clean it only as indicated to prevent damaging it. Never use solvents or other abrasive agents. The device comes with a dust cover to be used to protect it. Cover ALADDIN if it is not going to be used for a long period of time.

• •

Before turning on the device, remove the cover. Never put the cover on when the device is on.

6.7 Package contents • • • •

Power cable Manual Dust cover Accessory for the calibration check

ALADDIN

- User manual

Rev. 13 of 20/02/2013

NB: keep the original packaging for storage or transport of the device.

6.8 Checking the measurements •

It is absolutely essential to check calibration when the device has been transported from one place to another and when it has suffered an impact or thermal shocks.

•

It is recommended to check the measurements every day when turning on the device using the instrument provided.

• •

The user of the device must check that the measurements provided by the device are plausible. Before making measurements on patients, you need to know whether they are wearing contact lenses. If they are, some measurements might be incorrect. It is advisable to visually check all the light sources before examining patients to make sure that they come on properly.

•

If the device frequently emits error signals, turn it off and contact technical support to have the device checked.

•

With blue eyes, acquisition of pupillometry in mesopic lighting conditions can be difficult to accomplish. In this case, we suggest acquiring the mesopic data through dynamic pupillometry.

Product warranty and reliability •

The product warranty is valid only if all the instructions detailed in this document are followed.

•

The product warranty is forfeited in the event of loss or damage due to improper or incorrect use of the device. The product warranty is valid only if it is equipped with its original accessories.

• •

If the device is opened by unauthorised personnel, the manufacturer is relieved of all responsibility and the warranty shall become null and void.

•

N.B.: Modifications or repairs to the product, especially where they require opening the device, may only be carried out by technical personnel authorised by the manufacturer.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Legal provisions

93/42/EEC – 2007/47/EC: EN 60601-1: EN 60601-1-2: EN 60825-1: EN 62471: UNI EN ISO 19980

Class IIA medical device Class I type B EMC Laser class 1M All the sources are “EXEMPT GROUP” Type A

ALADDIN

- User manual

Rev. 13 of 20/02/2013

9 Components 9.1 Main Body

Placido disk

LCD display with touchscreen

Joystick with acquisition button

Semi-lock ON/OFF button Power connector (with fuse carrier) USB ports (2) LAN port Instrument locking devices for transportation

ALADDIN

- User manual

Rev. 13 of 20/02/2013

9.2 Other components

Forehead rest

Chin rest

Locking pins for chin rest papers

Wheel for adjusting the rest position

NB: The parts in contact with the patient are the forehead rest in silicon rubber and the chin rest in acrylonitrile butadiene styrene resin

ALADDIN

- User manual

Rev. 13 of 20/02/2013

10 Installation /uninstallation of the system ALADDIN is packed for shipping in a double cardboard box on a dedicated pallet with specially shaped cardboard parts inside to guarantee instrument safety during shipment.

Two special warning labels are applied on the outside of the cardboard box. Please check them as described below before accepting the instrument consignment, or accept it only with reserve. If the circle on the label shown below is white, it means that the instrument has been handled without tipping. If it is red, the instrument may have been damaged during shipping.

If the white rectangle on the label shown above is red in the middle, it means that the instrument may have been damaged by shock during transport.

Keep the original packaging for future use. The system must always be moved/shipped in its original packaging, specially designed to protect it against damage.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

10.1 Installing the system Before installing the system, read the “Safety Instructions” in this manual.

Figure 1

Figure 1 shows the complete packaging of the instrument. Cut the extensible film and the packing straps. Open the external box, and remove the wood panel as shown in Figura 2.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Figura 2 Remove the manual and the accessories from the dedicated spaces between the two pieces of cardboard (see Figura 3).

Figura 3

The accessories are: • “Topcon” box: o calibration checking device o chin rest paper o chin rest pins o touchscreen pen o silicon cloth • • •

Power cable “Topcon” ALADDIN dust cover ALADDIN user manual 24

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Open the internal box and remove the specially shaped cardboard that holds the instrument. Remove the Nylon cover. The instrument can now be taken out of the package. The sequence of steps is illustrated in Figure 4.

Figure 4

Be careful when taking ALADDIN out of the box gripping it by the chin rest arch and the base beside the joystick.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Place the instrument on a flat surface. Completely unscrew the two transportation locks and the semi-lock (Figure 5). Connect the power cable provided. The instrument is now ready for use.

Semi-lock

Instrument locking devices for transportation Figure 5

10.2 Uninstalling the system Take the original packaging.

Set the instrument to the minimum height using the joystick. Lock the device using the instrument semi-lock and the two “instrument locking devices” for transportation (Figure 5).

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Figure 6

Insert the instrument in the box, as shown in Figure 6, and place the Nylon cover over it. Follow the sequence of steps shown in Figure 7.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Figure 7

Put the accessories in the dedicated spaces. Position the wood panel with the shock absorbers in the lower part. Close the external box with strong packing tape or use extensible film and packing straps.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

11 ALADDIN accessories and equipment 11.1 Standard equipment •

Calibration checking device

The calibration checking device shows the serial number of the instrument with which it is associated. To properly check calibration, the calibrator provided with the instrument must always be used.

•

Power cable

•

Manual

•

Protective cover

•

Touchscreen pen

ALADDIN

- User manual

Rev. 13 of 20/02/2013

12 Setting up the instrument 12.1 Connection modes

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13 OPERATING INSTRUCTIONS ALADDIN is designed to work in stand-alone mode. For this reason, all the software functions are automatically loaded when the device is turned on, enabling the user to control the device and guiding him or her through the various phases: -

Entry of patient data Acquisition of the various possible modes Display of measurements Selection of intraocular lenses

More information for each function and the description of all the settings and other functions included is provided in the following paragraphs of this chapter, to which we refer you for further details. To interact with the software, the LCD display with touchscreen is used. To activate the button or the desired function, simply touch the screen close to the command. The screen is highly sensitive. Minimum pressure is required, indeed advised.

13.1 General description of functionalities The Aladdin device has the following functionalities:

• • • • •

Cornea image acquisition and topographic analysis.

•

Analysis of the wavefront aberrations generated by the front surface of the cornea with Zernike analysis: information on the cornea's optical properties and on the optical problems that can hinder vision.

•

Calculation of the intraocular lenses (IOL and Toric IOL), both PRE and POST refractive surgery (by means of the Camellin-Calossi formula).

Measurement of the eye's axial length. Measurement of the anterior chamber depth with the slit projection method. White-to-White measurement. Dynamic pupillometry acquisition: recording of a sequence of images of the pupil in varying light conditions. Acquisition of the static pupillometry in controlled light conditions (photopic and mesopic).

13.1.1 General instructions On the various screens displayed by the software there are symbols that provide access to certain functions available in several working environments.

Access to the "Settings" section, described in detail in the dedicated paragraph Direct printing of the report or saving of PDF file depending on the options selected in the print section.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.2 Checking the calibration It is absolutely essential to check the calibration when the device has been transported from one place to another and when it has suffered an impact or thermal shocks. It is highly recommended to check calibration of the device every day before starting patient examinations. Position the calibration tool (Figure 8) in the special holes in the chin rest. Check that the calibration instrument is perfectly aligned with the device. If the device is positioned correctly, all the rings of the Placido disk should be seen reflected in the centre on the surface of the hemisphere (Figure 9 ).

Figure 8

WRONG alignment

CORRECT alignment Figure 9

ALADDIN

- User manual

Rev. 13 of 20/02/2013 To check the calibration, turn on the instrument, and when asked to check the calibration, press OK. Now check and several times acquire the calibration checking device using the function “ALACD-K”. Compare the Axial Length, Anterior Chamber Depth and Keratometry measurements with the corresponding values shown on the labels of the calibration device. The measured values must be within the tolerance range of the values shown on the labels. If the measurements are out of the range, compared with those indicated on the calibration tool label, try acquiring at least two or three times more. If the calibration check is still out of the range or if there are substantial errors in the measurements, contact Topcon Technical Support to have the Aladdin instrument checked.

Figure 10

To complete the measurements, check that they are all within the tolerance range, click on “Main” to start a new examination, and when asked, press Yes to save the current “Calibration Check”. 33

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.3 Patient entry/selection When the instrument is turned on, the software displays the following screen. To continue the examination, you always need to enter a patient or select one from those on file.

Figure 11 Figure 11 shows the section for creating a new patient, entering Last Name, Name and Birth Date (Gender and ID are optional).

13.3.1 Creating a new patient To create a new patient, select the “New” tab and enter the data using the on-screen keyboard. Once you have entered the new patient data, click on the “Ok” button or select the “Acquisition” tab to confirm the information and continue with the examination. If you want to empty all the fields click on the “Clear” button. Before going into the acquisition environment, additional information on the patient is required, in particular the presence and type of crystalline and the nature of the vitreous humor (Figure 13). 13.3.1.1 Entering special characters: A special character can be entered simply by touching and holding the corresponding letter as shown in Figure 12:

Figure 12 34

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Figure 13

For each eye, select the type of crystalline currently present: • Phakic: the patient has a natural crystalline. • Aphakic: the patient does not have any crystalline from birth or as a result of surgery. • Pseudophakic: the patient has an artificial intraocular lens substituting the crystalline. In this case, it is very important to also detail the type of material used by the surgeon: o Unknown o Silicon o PMMA o Acrylate o Memory For the vitreous body you can choose between: • •

Natural: the vitreous body has never been operated or treated such as to alter its composition. Silicon Oil: the vitreous body has been filled, even only partly, with silicon oil.

All this information is required because, on the basis of the artificial materials and their optical properties present inside the eye, the instrument always corrects the measurements obtained to the most precise value possible. Once this information has been entered, you can access the acquisition environment. For more details on the acquisition environment see the dedicated section.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.3.2 Selecting or modifying a patient On the input screen, click on the "List" tab to access all the patients saved (see Figure 14).

Figure 14

On this screen you can select a previously created patient and the examinations associated with him/her. If you edit the “Last Name” fi el d, a search is done in the database for patients whose surname corresponds to or contains the selected key. Pressing the arrow button on the right cancels the field and the search. 13.3.2.1 Open an examination or acquire data for the selected patient In the left column, clicking on a patient in the “Exam List” fra me di s pl a ys the l i s t of a s s oci a ted

exa mina ti ons . In this list, you can access examinations or delete them, using the “Open” or “Delete” buttons. Selecting a patient and pressing on the "Acquisition” tab allows you to perform another examination for the selected patient. 13.3.2.2 Delete or edit the selected patient From the list of patients, select the exam you want to delete and press the "Delete" button. The program will ask you to confirm the choice. Press "Edit" to change the name, surname or date of birth. This takes you back to the initial "New" tab. From here, you can simply edit the one you want and press “Ok” or “Cancel” to confirm or cancel the changes.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.3.2.3 Insert the Post-Op (after surgery) refraction data Through this function the user can update the data related to a single exam of the chosen patient. This means that if the patient has already undergone surgery, the new refractive status can be recorded as a main factor to personalize constants of the implanted IOL.

Figure 15

Opening the Post-Op section, the screen shown Figure 15 will be displayed. In this section you can insert the Post-Op Data (IOL information plus actual refraction) in the meantime looking at the Pre Operative Data.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.4 Acquisition environment: general instructions

Figure 16

Figure 16 shows the acquisition screen. The joystick illustrated in Figure 17 is the only part the user has to physically control during acquisition. The button on the top marked "Acquisition button" starts the acquisition of the various measurements. The thumb wheel marked "Height Regulation" allows you to adjust the instrument's height according to the patient's position. On the chin rest there is also a knob for adjusting the height if the adjuster on the joystick is not enough to achieve the correct position. To perform the acquisition, position the patient with his/her chin on the chin rest and forehead on the forehead rest. This is the correct position for performing the examination.

The button is available in both eye columns; its function is to modify the nature of the Aqueous and Vitreous humor during the examination. The Axial Length will automatically be corrected depending on the new refractive index.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Figure 17

Make sure the patient's forehead is well up against the forehead rest

The position of the chin rest must be both comfortable and correct, i.e. it must allow the person performing the measurement to centre correctly on the fixation LED

Wheel for adjusting the chin rest height

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.4.1 Description of the Acquisition screen

Figure 18

Figure 18 shows the acquisition screen from where all the operations to acquire the required measurements are performed. The acquisition window has the following commands: • • • •

R and L: indicate the eye being acquired (the one highlighted in yellow); they are normally automatically selected, depending on the position into which you move the instrument. Biometry: gives access to the biometric measurement section Pupillometry: gives access to the pupillometry section buttons at the bottom of the data frame for each eye serve to scroll The the measurements, as some of these are hidden if more than four acquisitions are made per eye.

Correctly acquired measurements are displayed in yellow, wrong measurements are displayed in red.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.4.1.1 Errors in Measurements Sometimes the measurement is taken under critical conditions (not all the points of the rings are well measured, the palpebra is not open, the tear film is broken, ...); in this case, a warning sign appears above the measurement.

ATTENTION: When the symbol is shown above a measurement, it means that the software recognized an error during the acquisition, such as: bad focus, closed palpebra, tear film irregularity, high standard deviation in multiple measurements.

Figure 19

If a warning sign is shown above a measurement, it is recommended to make further acquisitions until reliable data is obtained. It is very important that all the types of measurement (KER-AL-ACD) taken are shown without a warning sign, otherwise it will not be possible to proceed to IOL Calculation with the current data. As shown in the figure above, accessing IOL Calculation, an error window will be shown warning the user to reacquire the measurements or to manually enter a new set of data. If the user proceeds with manual input, the software will pre-populate all the fields with acquired data, even those with warning signs. It is also possible to enter completely arbitrary data, possibly made with other instruments.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.4.1.2 Biometry Selecting the "Biometry" button, you can perform the axial length, anterior chamber depth and keratometry acquisitions either individually or in a full "AL-ACD-K" measurement, where the instrument executes all the measurements in sequence, i.e. • Axial Length • Anterior Chamber Depth • Keratometry To perform the measurements individually, simply click on one of the “AL” (axial length), “ACD” (anterior chamber depth) or “KER” (keratometry) buttons. WARNING: a correct ACD measurement cannot be made without acquiring the patient's keratometry. 13.4.1.3 Pupillometry Selecting the "Pupillometry" button gives access to the environment for the acquisition of the following measurements: • Dynamic pupillometry • Photopic pupillometry • Mesopic pupillometry

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.5 Full biometry acquisition (AL-ACD-K)

Figure 20

This is a special mode which successively performs all the measurements described in detail in the following paragraphs, specifically: - Axial length measurement - Anterior chamber depth - Acquisition of the topographic map with all associated measurements

13.5.1 Acquisition procedure Backlighting of the Placido disk is automatically activated when you enter the acquisition environment. If the instrument is not used for a few minutes, the cone turns off; to turn it on again, just press the joystick button. To acquire the image, or measurements in general, whatever mode you are in, simply proceed as follows: 1. Align the live image in the centre and focus, then press the joystick button to start the acquisition. 2. Move the instrument forwards and backwards (following the indications of the red and blue arrows on the screen) to find the best focus. 3. When the green indicators are displayed, press the joystick button again and the system will automatically capture the required image and/or measurements. Don’t move the joystick in the few seconds of acquisition time.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

The red arrows indicate to move the instrument forwards towards the patient's eye.

The blue arrows indicate to move the instrument backwards away from the patient.

The green icons indicate that the ideal focus has been reached. Press the joystick button to start the automatic acquisition procedure

13.5.2 Manual acquisition of the anterior chamber Acquisition of the anterior chamber depth requires more stringent parameters, depending on the conformation of the eye under examination. At the end of the automatic acquisition of K-values and axial length, ACD must be acquired manually following the alignment procedure.

Figure 21

The slit is turned on and you can proceed to centrally align the slit on the corneal apex. Follow the instructions of the red and blue arrows until optimum acquisition conditions have been reached and the software will automatically capture the image for the measurement.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.6 Acquisition of axial length measurements (AL)

Selecting this mode, the acquisition environment shown in Figure 22 appears.

Figure 22

The side columns show the measurements performed for the two eyes (R = right, L = left). For each acquisition, six measurements of the axial length are performed. The information displayed is the same as in “AL-ACD-K” acquisition.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.7 Acquisition of the anterior chamber measurement (ACD) Selecting this mode, the acquisition environment shown in Figure 23 appears. Press the joystick button and move the device according to the instructions of the automatic guidance system (red and blue arrows) until ideal conditions have been reached (green icons).

Figure 23

ALADDIN

- User manual

Rev. 13 of 20/02/2013

The acquisition proceeds by projecting a slit light beam onto the cornea ( Figure 24).

Figure 24

Follow the instructions of the red and blue arrows until optimum acquisition conditions have been reached and the software will automatically capture the image for the measurement.

In these conditions, the instrument records the anterior chamber depth. For more precise data, it is advisable to make a keratometry measurement beforehand.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.8 Keratometry acquisition (KER) Selecting this mode, the acquisition environment shown in Figure 25 appears.

Figure 25

In this mode, the topographic map of the cornea is acquired. As you can see, the keratometry data is evaluated in the right column, referring to the left eye. This section has the same interactions as the “AL-ACD-K” acquisition.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

13.9 Acquisition of the dynamic, photopic, mesopic pupillometry

Figure 26

Selecting this mode, the acquisition environment shown in Figure 26 appears. In order to acquire the pupillometry, you first of all need to centre the blue rectangle, which is overlaid in the image on the reflection of the four LEDs, as shown in Figure 27. Press the joystick button to start the acquisition and press the button again to stop the acquisition. As already mentioned in the introductory paragraphs, three types of acquisition can be performed: - Dynamic pupillometry - Photopic controlled light conditions (Photopic) - Mesopic controlled light conditions (Mesopic) In the case of the dynamic pupillometry, recording of the state of the pupil is started, first in mesopic conditions, then photopic and then mesopic again. The data on the diameters measured are recorded and shown in the "Measurement" section. For the dynamic acquisition, a sequence of images is recorded and allows you to "review" the evolution of the pupil through the various different light conditions to which it is subjected. In the pupillometry acquisition in static controlled light conditions: photopic and mesopic, certain frames are saved, which you can display by scrolling the associated gallery in the Pupil Measurements section. WARNING: With blue eyes, acquisition of pupillometry in mesopic lighting conditions can be difficult to accomplish. In this case, we suggest acquiring the mesopic data through dynamic pupillometry.

ALADDIN

- User manual

Rev. 13 of 20/02/2013

Acquisition in photopic controlled light conditions

Figure 27

Acquisition in mesopic controlled light conditions

Figure 28

Previous Page Next Page

TOPCON

ALADDIN Biometric System

ALADDIN User Manual Rev 13 Feb 2013